Galen North Pediatrics

Summary Statement of Deficiencies D0000 During a recertification survey completed on July 13, 2026, the laboratory was found out of compliance with the following conditions: 493.1409 Condition: Laboratories Performing Moderate Complexity Testing; Technical Consultant 493.1421 Condition: Laboratories Performing Moderate Complexity Testing; Testing Personnel D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) (c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (c)(1) Identity and when significant, titer, strength or concentration. (c)(2) Storage requirements. (c)(3) Preparation and expiration dates. (c)(4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on laboratory observation, review of the manufacturer's control package insert, review of laboratory policy, and staff interviews, the laboratory failed to label three of three control vials used for performing quality control on the Beckman Coulter DxH520 hematology analyzer with an open date and a revised expiration date on the survey date (07.13.2026). The findings include: 1. An observation of the laboratory on 07.13.2026 at 9:15 a.m. revealed a Beckman Coulter DxH520 hematology analyzer (Serial Number: BC111133) used for complete blood count with automated differential (CBC w/diff) patient testing. Observation also revealed three levels of DxH500 Series hematology controls (lot numbers: abnormal low-352618611, normal- 362618612, abnormal high-372618613) that lacked open dates and revised expiration dates. 2. A review of the manufacturer's control package insert revealed that "16* Open Vial Days, *Assumes that the Instructions for Use section of the Consumable IFU/Setting Sheet is performed a maximum of 16 times within 16 days, provided they are handled properly." 3. A review of the laboratory's "Reagent Storage/Preparation" procedure revealed, "Materials should be dated when received and again when opened Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- or reconstituted and if the expiration date changes after opening, the new expiration date should be written on the label." 4. An interview with the Office Manager on 07.13.2026 at 09:18 a.m. confirmed the survey findings above. Word key: IFU = Instructions for Use D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on laboratory observation and staff interview, the laboratory failed to ensure that it did not use blood collection tubes for reference laboratory patient testing past their expiration date on the date of the survey, 07.13.2026. The findings include: 1. Laboratory observation on 07.13.2026 at 9:15 a.m. revealed a drawer with blood collection supplies, which included 58 Becton Dickinson (BD) Lithium Heparin Microtainer blood collection tubes (46 of lot number: 418046N, expiration date: 12.31.2025, and 12 of lot number: 331018N, expiration date: 04.30.2025) for reference laboratory testing. 2. An interview with the Office Manager at 09:25 a.m. confirmed the above survey findings. D6033 TECHNICAL CONSULTANT-MODERATE COMPLEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: Based on a review of testing personnel competency assessments and personnel education verification records, the person(s) who performed testing personnel competency assessments did not meet the minimum requirements to perform technical consultant duties. (Refer to D6035 and D6053) D6035 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 (a) The technical consultant must be qualified and must possess a current license issued by the State in which the laboratory is located, if such licensing is required. (b) The technical consultant must-- (b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b)(1)(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology; or (b)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; AND (b)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in nonwaived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible (for example, physicians certified either in hematology or hematology and medical -- 2 of 5 -- oncology by the American Board of Internal Medicine are qualified to serve as the technical consultant in hematology); or (b)(3)(i)(A) Hold an earned doctoral or master's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution; or (b)(3)(i)(B) Meet either requirements in 493.1405(b)(3)(i)(B) or (b)(4)(i)(B) or (C); AND (b)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in nonwaived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(4)(i)(A) Have earned a bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution; or (b)(4)(i)(B) Meet 493.1405(b)(5)(i)(B); and (b)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in nonwaived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(5)(i) Have earned an associate degree in medical laboratory technology, medical laboratory science, or clinical laboratory science; and (b)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in nonwaived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible. (b)(6) For blood gas analysis, the individual must- (b)(6)(i) Be qualified under paragraph (b)(1), (2), (3) or (4) of this section; or (b)(6)(ii)(A) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; and (b)(6)(ii)(B) Have at least 2 years of laboratory training or experience, or both, in blood gas analysis; or (b) (7) Notwithstanding any other provision of this section, an individual is considered qualified as a technical consultant under this section if they were qualified and serving as a technical consultant for moderate complexity testing in a CLIA-certified laboratory as of December 28, 2024, and have done so continuously since December 28, 2024. This STANDARD is not met as evidenced by: Based on a review of testing personnel competency assessments, personnel education verification, and staff interviews, the personnel (TP1 and TP2) who performed technical consultant duties did not have the required education to perform those duties on the survey date (07.13.2026). The findings include: 1. A review of the laboratory's personnel records revealed the following: Competency Assessments signed by TP1 in the "reviewer signature & date" section: -TP2: Annual Competencies 03.06.2025 and 05.07.2026 -TP3: Initial Competency 03.06.2025 and Annual Competency 05.07.2026 -TP4: Initial Competency 03.06.2025 and Annual Competency 05.07.2026 -TP5: Initial Competency 05.07.2026 -TP6: Initial Competency 05.07.2026 -TP7: Initial Competency 05.07.2026 Competency Assessments signed by TP2 in the "reviewer signature & date" section: -TP1: Annual Competencies 03.06.2025 and 05.07.2026 2. A review of the documentation of the highest level of education revealed that TP1 and TP2 did not have the required education as defined in the regulations to perform the technical consultant duties. 3. An interview with the Office Manager and Technical Consultant on 07.13.2026 at 12:00 p.m. confirmed the above survey findings. Word Key: TP = Testing Personnel D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. -- 3 of 5 -- This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the Centers for Medicare and Medicaid Services (CMS) Laboratory Personnel Report (CLIA) (Form CMS-209), testing personnel (TP) records, and staff interview, the technical consultant failed to evaluate competency at least twice within the first year of patient testing for two of seven testing personnel in 2025. The findings include: 1. Observation of the laboratory on 07.13.2026 at 9:11 a.m. revealed a Beckman Coulter DxH 520 hematology analyzer (serial number BC111133) used for complete blood count with automated differential (CBC w/ diff) patient testing. 2. A review of Form CMS-209 revealed seven testing personnel who performed moderately complex patient testing for CBC w/ diff. 3. A review of testing personnel records revealed no documentation of competency twice annually during the first year of patient testing for TP3 (initial competency on 03.06.2025) and TP4 (initial competency on 03.06.2025). 4. An interview with the Office Manager and Technical Consultant on 07.13.2026 at 12:00 p. m. confirmed the survey findings above. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services (CMS) Laboratory Personnel Report (CLIA) (Form CMS-209), review of testing personnel (TP) records, and staff interviews, two of five new TP since the date of the last survey (11.04.2024), did not qualify to perform moderately complex complete blood count with automated differential (CBC w/ diff) patient testing due to a lack of documentation of the highest level of education. (Refer to D6065) D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; or (b)(2) Have earned a doctoral, master's, or bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology, or nursing from an accredited institution; or (b)(3) Meet the requirements in 493.1405(b)(3)(i)(B), (b)(4)(i)(B), (b)(4)(i)(C) or (b)(5)(i)(B); or (b)(4) Have earned an associate degree in a chemical, biological, clinical or medical laboratory science, or medical laboratory technology or nursing from an accredited institution; or (b)(5) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least a duration of 50 weeks and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(6)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on observation of the laboratory, a review of the Centers for Medicare and -- 4 of 5 -- Medicaid Services (CMS) Laboratory Personnel Report (CLIA) (Form CMS-209), review of testing personnel (TP) records, and staff interview, two of five new TP since the date of the last survey (11.04.2024), did not qualify to perform moderately complex complete blood count with automated differential (CBC w/ diff) patient testing due to a lack of documentation of the highest level of education on the survey date, 07.13.2026. The findings include: 1. Observation of the laboratory on 07.13.2026 at 9:11 a.m. revealed a Beckman Coulter DxH 520 hematology analyzer (serial number BC111133) used for moderately complex CBC w/ diff patient testing. 2. A review of the Form CMS-209 revealed seven TP (TP1, TP2, TP3, TP4, TP5, TP6, and TP7) listed as performing moderately complex CBC w/ diff patient testing. TP3, TP4, TP5, TP6, and TP7 were new testing personnel since the last survey (11.04.2024). 3. A review of TP records revealed no documentation of the highest level of education for TP6 and TP7. 4. An interview with the Office Manager and Technical Consultant on 07.13.2026 at 12:00 p.m. confirmed the above survey. -- 5 of 5 --

Summary Statement of Deficiencies D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on a review of the laboratory procedure manual and staff interview, the laboratory failed to establish a written policy or procedure defining the quality activities used to monitor, assess, and correct problems in the laboratory's testing systems for 2023 and 2024. The findings include: 1. A review of the laboratory procedure manual revealed no policy or procedure defining the laboratory's quality assessment activities used to monitor, assess, and correct problems in the laboratory's testing systems on the survey date (11/04/2024). 2. An interview with the office manager and laboratory consultant on 11/04/2024 at 1:30 p.m. confirmed that the laboratory did not have written quality assessment policies for monitoring and evaluating the pre-analytical, analytical, and post-analytical phases of the testing process. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- This STANDARD is not met as evidenced by: Based on a review of the laboratory procedure manual, environmental monitoring records, and staff interview, the laboratory failed to follow its temperature and humidity monitoring procedure for 23 of 24 months in 2022, 2023, and 2024. The findings include: 1. A review of the laboratory's "Temperature and Humidity Monitoring" policy revealed the following: - The laboratory is "to monitor room, incubator, refrigerator, and freezer temperature to assure reagent stability and room humidity of testing environment for quality instrument operation." - "In the event of a temperature or humidity that is found outside of acceptable range, steps must be taken to evaluate the contents of the storage container." - "Quality control logs containing temperature checks and eye wash station flush will be reviewed monthly." 2. A review of the laboratory's 2022, 2023, and 2024 "Monthly Temperature Checks" logs revealed the following: - The laboratory's acceptable room temperature range is 20 - 23 degrees Celsius(C). - The laboratory recorded the following room temperatures outside their established acceptable ranges: 23.2C on 11/03/2022, 23.4C on 11/11 /2022, 18.5C on 11/14/2022, 19.7C on 12/16/2022, 23.9C on 02/06/2023, 23.4C on 02 /23/2023, 23.5C on 03/02/2023, 23.4C on 03/31/2023, 23.4C on 08/09/2023, 19.7C on 11/13/2023, 19.7C on 11/27/2023, 19.9C on 12/19/2023, 19.7C on 12/21/2023, 19.9C on 12/22/2023, 19.1C on 01/29/2024, 23.2C on 04/08/2024, 23.4C on 04/11/2024, 23.2C on 04/30/2024, 23.4C on 06/03/2024, 23.4C on 06/05/2024, 23.4C on 06/19 /2024, 23.4C on 07/17/2024, and 23.4C on 07/31/2024. - The laboratory did not document any

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: ==================================== Based on review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) records, the Centers for Medicare and Medicaid Services Form 209 Laboratory Personnel Report (CMS-209) and interview with the laboratory technical consultant and lead testing person, determined that PT samples were not tested by all testing personnel listed on the CMS-209 in 2020, 2021, and 2022. The findings include: 1. Review of the laboratory's API Proficiency Testing Attestation records revealed only two of six testing personnel's signatures as testing PT samples (2020 Event 1, 2 and 3; 2021 Event 1 and 3; 2022 Event 1 and 2). 2. Review of the CMS-209 revealed six personnel who perform patient testing. 3. Interview with the technical consultant and lead testing person on September 22, 2022 at 11:30 am in the laboratory breakroom confirmed that PT samples were not tested by all testing personnel listed on the CMS-209 for 7 events in 2020, 2021, and 2022. ==================================== D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: ================================== Based on direct observation, review of laboratory environmental logs, review of laboratory's Beckman Coulter DxH 520 Operator's Manual, and interview with the technical consultant and lead testing person, determined the laboratory failed to document laboratory room temperature and humidity for 32 of 32 months (01/2020 through 08/2022). The findings include: 1. During a tour of the laboratory on 09.22.2022 at 9:15 A.M., the surveyor observed a Beckman Coulter DxH 520 CBC analyzer on the laboratory counter. 2. Review of laboratory environmental logs revealed laboratory failed to document laboratory room temperature and room humidity for 32 of 32 months (01/2020 through 08/2022). 3. Review of the laboratory's Beckman Coulter DxH520 Operator's Manual, stated, "The instrument configured with DxH 520 consumables meets performance specifications when operated at a temperature of +18 to 32 degrees Celsius (64.4 to 89.6 degrees F). The instrument meets performance claims when operated at a maximum of 80% relative humidity (non-condensing) at 32 degrees Celsius (89.6 degrees F)." 4. Interview with laboratory technical consultant and lead testing person at 11:45 am on 09.22.2022 in the laboratory brekroom confirmed the above findings. ================================= -- 2 of 2 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: =================================== Hematology: The laboratory failed to maintain satisfactory participation in two consecutive events for the Hemoglobin (HGB) and White Blood Cell (WBC) analytes resulting in the initial unsuccessful proficiency testing (PT) occurrence for HGB and WBC. (Refer to D2130) =================================== D2130 HEMATOLOGY CFR(s): 493.851(f) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: =================================== Based on a desk review of the CMS CASPER Report 0155D and the laboratory's 2021 Proficiency Testing (PT) performance summary records from the American Proficiency Institute (API) Proficiency Testing program, the laboratory failed to maintain satisfactory performance for the Hemoglobin (HGB) and White Blood Cell (WBC) analytes in the 1st event 2021 and 2nd event 2021, resulting in the initial unsuccessful PT occurrence. The findings include: 1. A review of the CMS 0155D report revealed an unsatisfactory HGB analyte score of 40% and unsatisfactory WBC analyte score of 60% for the 1st event of 2021 and unsatisfactory HGB and WBC analyte scores of 0% for the 2nd event of 2021. 2. A review of the laboratory's API Proficiency Testing records revealed an unsatisfactory HGB analyte score of 40% and unsatisfactory WBC analyte score of 60% for the 1st event of 2021 and unsatisfactory HGB and WBC analyte scores of 0% for the 2nd event of 2021. =================================== -- 2 of 2 --

Summary Statement of Deficiencies D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: ==================================== Based on review of Complete Blood Count (CBC) quality control (QC) on 4/13/18, patient reports and interview with Technical Consultant, the laboratory failed to meet QC criteria prior to reporting patients. The findings include: 1. Review of CBC quality controls on 4/13/18 revealed normal and high controls (lot#'s: 079200 and 089200) for platelets failed to meet acceptable QC criteria. 2. Review of patient CBC's on 4/13/18 revealed 11 patients reported. 3. Interview with the Technical Consultant at 12:30 p.m. April 9, 2019 confirmed that 2 levels of CBC quality controls failed to meet acceptable criteria for platelets and 11 patients were reported. ===================================== Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --